5 Most Important Psychedelic Clinical Trials in 2022 | Psychedelic Spotlight

In 2022, psychedelics such as MDMA, psilocybin and LSD are closer than ever to being legalized for medical purposes. While psychonauts have known about their potential to help mental health conditions such as depression, anxiety and trauma for generations, the medical establishment has been slow to recognize psychedelic drug potential.

But now that they have taken notice of these mind-altering substances they are…well, okay, they are still moving slowly. But, that is by design. In order for a new medicine to be approved for use in the United States, we need to be absolutely certain that it is both safe and effective. That takes time.

To ensure this, potential new medicines, including psychedelics, must pass through the clinical trial framework. In short, there are 3 phases a drug must succeed in, aptly named: Phase 1; Phase 2; and Phase 3. Phase 1 solely tests safety in a small group of around a dozen healthy people. Phase 2 tests the efficacy of the drug in treating a specific condition, such as depression, in several dozen people. Often, Phase 2 is split into Phase 2a and Phase 2b, where the first tests multiple different dose levels against each other to see which is most effective, and the latter uses just the dose determined to be best. Finally, if a compound has successfully passed both previous phases, it must complete Phase 3, where efficacy is again tested, but often in a larger group of around 100+ people. In order for the drug to be approved for use, it must complete two Phase 3 trials, with results showing that it is more effective or safer than current medications.

In this article, I aim to highlight the five most significant clinical trials that are either currently underway, or are set to begin in 2022. These trials will be make it or break it tests for whether MDMA, psilocybin, LSD, DMT and ketamine will ultimately be legalized for therapeutic use throughout the USA and the West more broadly.

MAPS’ Phase 3 Trial: Treating PTSD with MDMA Therapy

Of all the trials listed here, MAPS’ is the furthest progressed. This trial, currently recruiting patients and set to begin this year, will be MAPS’ second Phase 3 clinical trial attempting to treat PTSD with MDMA-assisted therapy.

The first had phenomenal, paradigm shifting results. In it, 88% of patients with severe PTSD who received MDMA-assisted therapy saw their symptoms decrease by 50% or more. Even more impressive, a full 67% of patients who received the psychedelic “no longer met the diagnostic criteria for PTSD.” That sounds an awful lot like a cure for those people.

If MAPS can repeat these findings in a second Phase 3 trial, then MDMA-assisted therapy to treat PTSD will likely become legalized in the US. In fact, if you listen to Rick Doblin, Executive Director of MAPS, he expects MDMA-therapy for PTSD to be legalized before the end of 2023.

It is hard to believe that as slowly as the clinical trial process moves, it is possible that we could see the first psychedelic…